Systems and methods for volume reduction

ABSTRACT

Systems and methods are provided for reducing the effective volume of a cardiac ventricle. A ventricular volume reduction system may include a containment system or container body deliverable through a catheter into the ventricle, with the containment system or container body being fillable to occupy space within the ventricle. A ventricular volume reduction system may include a partition that sequesters a portion of the ventricle and separates it from the flow path of blood in the ventricle. Methods for reducing the effective ventricular chamber volume may include placement of the containment system, the container body or the partition within the ventricle.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.12/187,287, filed Aug. 6, 2008, which is a continuation of InternationalPCT Application No. PCT/US2007/061679 filed Feb. 6, 2007 which claimsthe benefit of U.S. Provisional Application No. 60/765,158, filed Feb.6, 2006, all of which are incorporated herein by reference in theirentireties.

BACKGROUND OF THE INVENTION

This invention relates to systems and methods for reducing the volume ofthe left or right ventricles of the heart, thereby to facilitatetreatment of congestive heart failure, ventricular aneurysms or otherrelated conditions.

A spectrum of disease processes may affect the pumping capability of theheart, impairing its ability to provide adequate circulation for themetabolic needs of the tissues and organs of the body. Diseases specificto the heart include those that 1) interfere with theelectrophysiological conduction to the heart; 2) interfere with theinflow or outflow of blood through a heart valve; or 3) affect themyocardium itself, whether by ischemic damage or intrinsiccardiomyopathy. Certain conditions may be improved by medical orsurgical interventions, so that the heart is able to pump what the bodyrequires. A conduction problem can be corrected, for example, by apacemaker. An abnormal heart valve may be replaced.

Unfortunately, lesions of the cardiac muscle itself are more difficult,if not impossible, to repair at present. Techniques involving muscleregeneration by stem cells, for example, do not yet permit reliablerestoration of functional myocardium. Instead, when the myocardium isinjured, muscle cells that die are typically replaced withnon-contractile scar tissue, and muscle cells that have been sublethallydamaged may not contract normally. As a result, the heart may lose itsability to pump adequately. Impairment of the heart's contractilecapability, if sufficiently severe or advanced, may result in diminishedcardiac output (so-called forward failure), damming up of venous return(so-called backward failure), or both. These end results collectivelyform part of the syndrome of congestive heart failure (CHF).

Other CHF signs and symptoms are caused by the body's attempt tocompensate for inadequate cardiac pumping. When the heart is not pumpingenough blood to meet the body's demands, the body activates a number ofcompensatory physiologic mechanisms. If these physiological mechanismsare ineffective to restore adequate circulation, or if they becomeoverextended, they no longer permit compensation. Instead, the systemdecompensates and may tip over into CHF.

Understanding the pathophysiology of CHF therefore involvesunderstanding the compensatory mechanisms by which the heart responds toa mismatch between the body's metabolic needs and the heart's pumpingcapabilities. These compensatory mechanisms include: 1) theFrank-Starling mechanism, by which preload is increased to enhancecardiac performance; 2) myocardial hypertrophy, with an increase ofcontractile cell mass; 3) cardiac chamber dilation; and 4) neurohumoraladaptation, including the activation of therenin-angiotensin-aldosterone system and the release of norepinephrine.Under normal circumstances, these mechanisms work together to meetincreased circulatory demands during exercise, stress or fever. When thedemand on these adaptive mechanisms is too great, perhaps because ofexcessive metabolic requirements or inadequate pumping capability, theadaptive mechanisms themselves become maladaptive.

Under normal conditions, the heart responds to increasing demands byaugmenting preload, increasing the heart rate, and increasing thecontractility of the ventricles. An increase in preload leads to anincreased stretch of the myocardial fibers. As a result, the force ofthe next cardiac contraction is increased, as described by theFrank-Starling curve. According to the Frank-Starling mechanism, themore the heart fills during diastole, the greater the force ofcontraction during the next systole. With overfilling of the heart,however, the cardiac muscle fibers become overstretched and thismechanism becomes ineffective. After a certain degree of stretch, thefibers no longer respond to increasing stretch by increasingcontractility. Instead, their contractility diminishes. Theoverstretched heart becomes less able to pump, and the ventricles maydilate.

Over a longer period of time, cardiac muscle responds to increasing workdemands by increasing in size, just like skeletal muscle. The cardiacmuscle cells cannot increase in number, but can only increase in size.This mechanism is called hypertrophy. With myocardial hypertrophy, theventricular wall thickness may increase and the ventricle may enlarge asthe myocardial fibers elongate. The myocardial cell proteins formedduring hypertrophy may be abnormal, however, which may affect theirfunctional efficacy. Hypertrophy may also increase the myocardium'smetabolic demands, such that these demands outstrip the circulatorysupply.

Other cardiac compensatory mechanisms, such as increases in heart rateand contractility that are brought about by norepinephrine stimulationmay exacerbate functional decompensation of the heart, because themetabolic needs of the cardiac muscle may increase beyond thecirculation's ability to satisfy them. In addition, non-cardiaccompensatory mechanisms set in motion by decreased cardiac output orcontractility may also have adverse effects on myocardial function. Forexample, as the body compensates for decreased cardiac output byretaining sodium and water, there may be increased ventriculardistention and a subsequent decrease in contractile efficiency. The bodymay respond by an additional increase in heart rate, increasing themyocardium's metabolic demands even further.

Where the compensatory mechanisms have lost their ability to improvecardiac performance appropriately or when the patient shows symptomsderived from the compensatory mechanisms or the underlying cardiacperformance problem, medical intervention is warranted. Pharmacologicaltreatment for CHF generally endeavors to increase myocardialcontractility or to affect the now-dysfunctional compensationmechanisms. Three general classes of drugs have been found useful: 1)inotropic agents, which increase the strength of cardiac musclecontraction; 2) vasodilators, which decrease the resistance and head ofpressure against which the heart must pump; and 3) diuretic agents,which counteract fluid retention and preload.

The New York Heart Association has proposed a useful functionalclassification system for CHF. Class I patients are not limited bycardiac symptoms and may engage in normal physical activity. Class IIpatients suffer symptoms like fatigue or dyspnea during ordinaryphysical activity. Class III patients experience a significantlimitation of normal physical activities. Class IV patients suffersymptoms at rest or with any physical exertion. Pharmacologicalintervention may improve a patient's cardiac status sufficiently so thatthe person may enjoy an acceptable quality of life.

CHF, however, is accompanied by a grim prognosis. CHF patients mayrequire multiple hospital admissions for management, and may deterioratedespite aggressive medical management. The majority of CHF patients maydie within several years of diagnosis. NYHA Class IV patients mayexperience a 65% one-year mortality.

Heart transplantation has assumed a central role in the treatment ofadvanced CHF in certain patients. Transplantation, however, is a limitedoption, because of the restricted supply of donor organs and the needfor immunosuppression. Nearly 5 million patients in the U.S. suffer fromCHF. Approximately 500,000 patients are newly diagnosed each year. Yetfewer than 3,000 heart transplants are performed for this conditionannually in the U.S., well below the number required to treat severelyafflicted patients.

Standard surgical procedures such as coronary revascularization andmitral valve replacement are understood to be beneficial for certain CHFpatients. Reconstruction of the mitral subvalvular apparatus may alsoimprove left ventricular function in CHF patients. Implantableventricular assist devices may provide temporary cardiac output supportfor CHF patients. A variety of surgical techniques permit reconstructionof the left ventricle itself, for example to treat a dyskinetic aneurysmor an akinetic segment following infarction. Partial leftventriculectomy may also involve excising viable but hypocontractilemyocardium, to permit remodeling of the overstretched left ventricle.Dynamic cardiomyoplasty uses the patient's own skeletal muscle (e.g.,the latissimus dorsi) to assist the heart in pumping and/or to decreasethe stress on the myocardial wall. Passive ventricular constraintdevices have been developed to improve cardiac function. For example,the Acorn CorCap™ offers flexible external constraint. In addition,devices may be positioned within the heart to constrain the size and/orshape of the ventricle.

There remains a need in the art for a treatment modality for CHF thathelps to improve the anatomy and physiology of the failing leftventricle. A need also exists for a CHF treatment device that isadjustable once applied to the left ventricle, so that it can moreclosely adapt to the anatomic and physiological needs of the patient.Furthermore, there is a need for a device that is implantable usingminimally invasive or catheter-based techniques in severely compromisedCHF patients.

SUMMARY OF THE INVENTION

Provided herein are systems and methods for ventricular volumereduction.

A ventricular chamber volume reduction system disclosed herein comprisesa containment system deliverable through an intravascular catheter intoa ventricular chamber and expandable from a collapsed shape to a filledshape once delivered into the ventricular chamber; and a filler withinthe containment system, for example a resilient or non-resilient shellwherein the filler expands the containment system from the collapsedshape to the filled shape, and wherein the filled shape reduces volumeof the ventricular chamber. The system reduces the chamber volume in aventricular chamber, thereby reducing the effective volume of theventricle. The term “effective volume” refers to the volume of bloodthat is ejected from the ventricle during systole or the volume of bloodthat is retained in the ventricle during diastole. The containmentsystem may comprise an elastomeric component. The filler may be curable.The filler may comprise a polymer, which may be hydrophilic. The fillermay be delivered by a catheter. The filler may reside within thecontainment system when the containment system is in the collapsedshape. The containment system may retain itself within the ventricularchamber. The retainment mechanism may be a self-expanding support orframe. The system may further comprise attachment mechanisms that affixthe containment system to a wall of the ventricular chamber.

The system may further comprise a fillport for the containment system.The fillport may be adapted for delivery of additional filler to thecontainment system when the containment system is positioned within theventricular chamber. The fillport may be adapted for removal of fillerfrom the containment system when the containment system is positionedwithin the ventricular chamber. The fillport may be adapted for deliveryof a fluid into the containment system when the containment system ispositioned within the ventricular chamber. The fillport may be adaptedfor removal of fluid from the containment system when the containmentsystem is positioned within the ventricular chamber.

A ventricular chamber volume reduction system disclosed herein cancomprise a container body deliverable into a ventricular chamber andexpandable from a first shape to a second shape when delivered into theventricular chamber, the container body having a tissue surface incontact with a wall of the ventricular chamber and an exposed surfacefacing into the ventricular chamber, wherein the second shape of thecontainer body occupies space in the ventricular chamber, therebyreducing ventricular volume. The system reduces the chamber volume in aventricular chamber, thereby reducing the effective volume of theventricle. The container body comprises a reinforcement frameworkdimensionally adapted for supporting the second shape of the containerbody. The first shape of the container body is dimensionally adapted fordelivery through a catheter. The container body comprises an attachmentdevice that affixes the tissue surface to the wall of the ventricularchamber.

A ventricular chamber volume reduction system disclosed herein cancomprise a partition sequestering a portion of a ventricular chamber,thereby removing the portion from a flow path for blood flowing withinthe ventricular chamber, the partition having an exposed surface facingthe flow path and a support to secure its position within theventricular chamber, wherein placement of the partition decreases volumeof blood flowing along the flow path within the ventricular chamber. Thepartition may reduce the volume of blood ejected during systole or theamount of blood retained during diastole. The system reduces the chambervolume in a ventricular chamber, thereby reducing the effective volumeof the ventricle. The partition may further comprise an antithromboticagent and/or other medicaments.

The system may further comprise a support intrinsic to the partition.The support may be affixed to the wall of the ventricular chamber. Thesupport may further comprise a plurality of ribs reinforcing thepartition. The system may further comprise a framework affixed to thepartition. The framework may further comprise a tether attaching thepartition to a wall of the ventricular chamber. The framework may applya contractile force to the wall of the ventricular chamber. Theframework may comprise an elastomeric material.

The system may further comprise an anchor to attach the partitiondirectly to the wall of the ventricular chamber. In embodiments, thesystem may further comprise a filler occupying the portion of theventricular chamber sequestered by the partition. The system may furthercomprise a solid body occupying the portion of the ventricular chambersequestered by the partition. A solid body may include any solidstructure dimensionally adapted for occupying space within thepartitioned portion of the ventricular chamber. The system may furthercomprise an expandable body occupying the portion of the ventricularchamber sequestered by the partition.

Methods for reducing ventricular volume disclosed herein can comprisedelivering a containment system into a ventricular chamber and expandingthe containment system from a collapsed shape to a filled shape withinthe ventricular chamber, thereby reducing ventricular volume. The filledshape of the containment system may be affixed within the ventricularchamber.

Methods for reducing ventricular volume disclosed herein can comprisedelivering a container body into a ventricular chamber, and expandingthe container body from a first shape to a second shape, wherein thesecond shape occupies space in the ventricular chamber, thereby reducingventricular volume. The container body may be affixed within theventricular chamber.

Methods for reducing effective ventricular volume disclosed herein cancomprise partitioning a ventricular chamber into a flow path and ano-flow path, thereby reducing effective ventricular chamber volume. Aflow path is understood to be a volume of the ventricle through whichcirculating blood flows. A no-flow path is understood to be a volume ofthe ventricle that is sequestered from the flow path, so that it is notaccessible to circulating blood.

BRIEF DESCRIPTION OF FIGURES

The systems and methods described herein may be understood by referenceto the following figures:

FIG. 1 shows a partial cut-away view of a human heart FIGS. 2 a and 2 bpartial cut-away views of a human heart illustrating, respectively,normal anatomy and certain anatomic changes accompanying congestiveheart failure.

FIG. 3 shows a partial cut-away view of a human heart illustrating thetransaortic placement of a delivery catheter.

FIG. 4 shows a partial cut-away view of a human heart illustrating theplacement of a volume reduction device via a delivery catheter.

FIG. 5 illustrates a variation of a volume reduction device.

FIG. 6 shows a partial cut-away view of a human heart illustrating avariation of a volume reduction device positioned in the left ventricle.

FIG. 7 shows a partial cut-away view of a human heart illustrating avariation of a volume reduction device positioned in the left ventricle.

FIGS. 8 through 12 illustrate variations of the volume reduction systemin various configurations.

FIGS. 13 a through 13 f illustrate variations of cross-section A-A ofFIG. 12.

FIG. 14 illustrates a variation of the volume reduction system.

FIGS. 15 and 16 illustrate variations of the volume reduction system.

FIGS. 17 and 18 illustrate a top view of the variation of the volumereduction system of FIG. 15 in deflated and inflated configurations,respectively, not to scale.

FIG. 19 illustrates a variation of a cover.

FIGS. 20 and 21 illustrate a variation of a method for deploying avariation of the volume reduction system in the left ventricle.

FIGS. 22 and 23 illustrate a variation of a method for deploying avariation of the volume reduction system in the left ventricle.

FIG. 24 illustrates a variation of a method for inflating a variation ofthe volume reduction system in the left ventricle.

FIG. 25 illustrates a method of using a variation of the volumereduction system in the left ventricle.

FIGS. 26 through 29 illustrate a variation of a method for deploying avolume reduction system in a fallopian tube, for example, forsterilization.

FIGS. 30 through 33 illustrate a variation of a method for deploying avolume reduction system in a fallopian tube, for example, for digestioncontrol and/or appetite suppression.

FIG. 34 illustrates a variation of cross-section B-B of FIG. 33.

DETAILED DESCRIPTION OF FIGURES

FIG. 1 illustrates the structures of the human heart 100. In moredetail, a right ventricle 20 and a left ventricle 22 are shown. Bloodreturning from the systemic circulation passes into the heart 100through the superior vena cava 28 and the inferior vena cava 30,thereafter entering the right atrium 24 of the heart 100. Thedeoxygenated blood passes from the right atrium 24 through the tricuspidvalve 32 into the right ventricle 20. The right ventricle 20 pumps theblood through the pulmonic valve 34 into the pulmonary artery 36, whichconducts the deoxygenated blood into the lungs. Oxygenated blood returnsto the heart 100 through the pulmonary veins 38. The blood then entersthe left atrium 26 and passes through the mitral valve 40 into the leftventricle 22. The left ventricle 22 pumps the oxygenated blood throughthe aortic valve 42 into the aorta 44 for distribution into the systemiccirculation.

FIG. 2 a schematically illustrates normal cardiac anatomy. The rightventricle 106 and the left ventricle 108 are normally sized and shaped.Arrows in the diagram represent the path of blood flow through the leftside of the heart. The arrow 102 is sized to represent a normal cardiacoutput, consistent with the normal physiology shown in FIG. 2 a. In anormal heart, the ejection fraction (the volume of blood ejected dividedby the total ventricular volume) is typically greater than 60%.

FIG. 2 b schematically illustrates certain changes in cardiac anatomyand physiology under conditions of congestive heart failure (CHF). Thearrow 110 is sized to represent a decreased cardiac output, consistentwith the hemodynamics of CHF. In severe CHF, cardiac output may bedecreased and end-diastolic ventricular volume may be increased. Theejection fraction may be as low as 20-30%. As depicted in FIG. 2 b, theleft ventricle 112 is dilated and the ventricular wall 118 is thinned.The position of one of the chordae tendinae 114 and papillary muscles116 is also schematically depicted. With dilation of the ventricle 112,the relative positions of these structures may be altered, affectingtheir ability to tether the mitral valve 40 during ventricularcontraction. With severe CHF, the alteration of mitral valve 40 geometryor of the tethering apparatus may result in mitral valve 40regurgitation.

The systems and methods in this specification are described withreference to the generalized anatomy and physiology of congestive heartfailure as depicted in FIG. 2 b. Decreasing the left ventricular volumein CHF may improve the ejection fraction and may stabilize or improveCHF symptoms. The systems and methods described below may act as staticspace occupying structures that passively decrease ventricular volume.These systems and methods may further have dynamic properties, acting topull the myocardial walls inward for example, thereby further decreasingventricular volume.

The systems and methods described below would be applicable to otheranatomic conditions, including ventricular aneurysms and dyskineticventricular segments. Adaptations of the systems and methods disclosedherein may be provided to address such conditions, requiring no morethan routine experimentation. The systems and methods disclosed hereinmay be adapted for treatment of related anatomic abnormalities such asmitral regurgitation, dilation of the mitral valve annulus and the like.The systems and methods described herein may be combined with any otheractive or passive system to exert a static or dynamic force on the leftventricular wall, the anatomic components of the ventricular wall, themitral valve or its supporting structures.

As depicted in FIG. 3, a system constructed in accordance with theprinciples of the present invention may permit the delivery of anexpandable device into the dilated left ventricle 112 of a patient withCHF. To enter the left ventricle 112, a catheter-type delivery device120 may be used. As would be understood by those of ordinary skill inthe art, such a delivery device 120 could be inserted into the ventricleretrograde through the arterial system, crossing the aortic valve 42.Other placement routes can be used. For example, the delivery catheter120 could be passed transvenously into the right atrium and thendirected across the intraatrial septum via puncture to enter the leftatrium, crossing the mitral valve to enter the left ventricle 112. Whileminimally invasive delivery is desirable, using for example acatheter-type delivery device 120, other delivery methods may also beenvisioned. For example, a thoracoscopic technique may be used, or anopen surgical technique. In addition, the volume reduction devicedescribed herein may be delivered as an adjunct to another procedure,for example a coronary artery bypass or a valve replacement. Otherplacement methods may be envisioned by those of ordinary skill.

FIG. 4 illustrates steps of the delivery of a volume reduction systeminto the left ventricle 112. As depicted in this figure, a volumereduction system may comprise one or more containment systems 130, forexample a fluid and/or gel and/or solid containment element or system.The containment systems 130 can be filled with one or more fillermaterials 132. The catheter 120 may maneuver into position within theleft ventricle 112. The catheter 120 may deliver the volume reductiondevice containment system 130 into the ventricle 112. The containmentsystem 130 may be inserted into the ventricle in a first, collapsedshape. The catheter 120 may be used to position the containment system130 so that the containment system 130 seats properly in the ventricle112, for example against the ventricular wall 134. Practitioners ofordinary skill may be able to determine how best to position thecontainment system 130 in the ventricle 112, avoiding, for example,interference with the functioning of the papillary muscles (as depictedin FIG. 2 b), or avoiding impingement upon the chordae tendinae (asdepicted in FIG. 2 b).

A containment system 130 may be made of any biocompatible material thatsuitably contains the filler material 132. The containment system 130can be formed from an elastomeric material. The elastomeric material canpermit the filled containment system 130 to flex in response toventricular contractions. The containment system 130 may be formed fromseveral different materials, or from materials whose stress-straincharacteristics permit differential stiffness and/or flexing in onedirection preferentially. The containment system 130 may be formed fromePTFE, PTFE, from silicone, or from other polymers, as would beunderstood by those of ordinary skill in the art.

After the delivery of the containment system 130 into the ventricle 112,or simultaneous with extrusion of the containment system 130 from thecatheter 120, a filler material 132 may be delivered into thecontainment system 130. The containment system may have independentcompartments that may be filled independently to varying pressure or maybe filled with different materials. Insertion of the filler material 132may expand the containment system to a second, filled shape. Thecatheter 120 may be used to position the containment system 130 withinthe ventricle 112 as it is being filled or after it has been filled. Thecontainment system 130 may be prefilled with a hydrophilic filler thatabsorbs water and thus expands to a filled shape. The catheter 120 maybe used to apply force to the filled containment system 130 to attach itto the ventricle wall 134. The catheter 120 may also provide mechanismsfor activating ancillary structures that form part of the volumereduction system, as will be described in more detail below.

As shown in this figure, a filling port 122 may be placed in theproximal end of the containment system 130 through which filler material132 enters the containment system. A filling port 122 may beself-sealing, so that it seals permanently when the catheter is detachedfrom the containment system 130. The filling port 122 may permitrepeated access, so that the volume of filler material 132 may beadjusted by subsequent catheterizations. A suitable filling port 122permitting repeated access by subsequent catheterization may have ascrew mechanism, a latch mechanism, or any other mechanism that wouldpermit detachable attachment of a filling device. The filling port 122may include a valve (not shown), such as a flap valve or ball valve. Atwo-way valve structure may permit both filling and emptying of thefiller material 132. The filling port 122 may also be accessible by aneedle to add or remove filler material 132. Adjustability of fillingvolume may permit the physician to increase or to decrease the spacewithin the ventricle 112 occupied by the volume reduction system.

The containment system 130 may be overfilled using a first fillermaterial 132 a (not shown). The first filler material 132 a may beremoved and replaced by a smaller volume of a second filler material 132b (not shown). Alternatively, a portion of the first filler material 132may be removed to adjust the volume as desired. The initial process ofoverexpansion may enhance the seating of the filled containment system130 within the ventricle 112.

Appropriate filler material 132 may include biocompatible gases orliquids. The filler material 132 may be a saline solution or any otherbiocompatible solution, including polymeric materials, polyethyleneglycols, collagen solutions, fibrin solutions, water, blood, gas (e.g.,carbon dioxide, air, oxygen, nitrogen, nitrous oxide), and combinationsthereof. The filler material 132 may be curable or may otherwise changeits viscosity and physical properties before or after filling. Thefiller material 132 is cured or hardened to provide for a permanentimplant having, for example, a fixed size and shape conforming to theanatomy of the ventricle 112. Methods for curing or hardening the fillermaterial 132 are specific for particular filler materials 132. Forexample, certain polymers may be cured by exposure to ultraviolet lightor to heat, including body heat. Other curing systems may be set up bymixing two polymers together. In such a case, the catheter 120 maypermit delivery of the two component polymers, so that their mixinginside the containment system 130 will result in a single cured fillermaterial 132. Certain polymers may be mixed immediately before use, andthen inserted through the catheter 120 into the containment system 130,with the expectation that they will cure within the containment system130 within a predetermined time. Curing need not result in a firm fillermaterial 132. Elastomers, gels, sols, foams and other liquid, semisolidor solid filler materials 132 and the like having a range ofconsistencies from soft to firm, may be suitable for these purposes.Radiopaque marker materials may be used as filler materials 132 or maybe added to filler materials 132.

The filler material 132 may possess contractile properties, or maycontract when cured so that it urges the volume reduction system todecrease its volume. If the containment system 130 of the volumereduction system has been affixed firmly to the ventricular wall 134,contraction of the filler material 132 may exert an inward pull on theventricular wall 134, thereby further reducing ventricular volume.

FIG. 5 depicts a volume reduction system 160 seated within the leftventricle 112. As shown in this figure, a volume reduction system 160may include a volume reduction container body 162 that contains fillermaterial as described above. The container body 162 can have a tissuesurface 164 that abuts the ventricular wall 134, and has an exposedsurface 166 that is in contact with free-flowing blood in the cavity ofthe left ventricle 112.

The container body 162 can abut against the ventricular wall 134 and maysubstantially conform to its shape. The solidifying of the fillermaterial (not shown) may enhance the conformity of the container body162 to the irregularities of the ventricular wall 134. Conformity of thecontainer body 162 to the wall can facilitate its retention in theventricle 112. The tissue surface 164 of the container body 162 may bemodified to enhance attachment, for example by facilitatingendothelialization or other physiological anchorage. For example, thetissue surface 164 may be textured, or may be covered with a fabric ormesh that would provide a template for tissue ingrowth. Any surfaces ofthe container body 162 may bear radioopaque markers, may containradioopaque filler material, or may otherwise be radioopaque.

The exposed surface 166 may be part of the same assembly as thecontainer body 162. For example, a balloon-like container body 162 mayassume a spherical or ovoid shape that nestles distally in the apex ofthe ventricle 112, and that protrudes convexly into the chamber of theventricle 112. The superior aspect of the container body 162 protrudinginto the ventricle 112 can itself form the exposed surface 166.

Such as depicted in FIG. 5, the exposed surface 166 may assume its owngeometry, apart from the shape assumed by the container body 162. Asshown in FIG. 5, a two-part assembly with a container body 162 elementand an exposed surface 166 element can be joined together. The containerbody 162 and the exposed surface 166 may be made from differentmaterials, each having different physical properties. For example, thecontainer body 162 may be made from a highly elastic material thatallows it readily to conform to the interior configurations of theventricle 112, while the exposed surface 166 may be a stiffer materialthat is inclined to assume a predetermined shape. The container body 162may be an integral assembly with the exposed surface 166 but thegeometry of the unit may be determined in part by the materials fromwhich each aspect is formed, or may be determined in part by anyframework or support included within the substance of the unit.

It is understood that the exposed surface 166 will be in contact withfree-flowing blood. Therefore, anti-thrombotic materials are desirablefor the exposed surface 166, as is a shape that avoids areas of stasis.Resistance to thrombosis may be inherent in the selected materialforming the exposed surface 166, or it may be produced by applying asuitable coating to or embedding a suitable antithrombotic material inthe biomaterial comprising the exposed surface 166.

Reinforcement materials may be embedded in or integrated into thecomponents of the volume reduction system. Such reinforcement materialsmay include struts or stents included in the container body 162 or theexposed surface 166. The reinforcement materials may cause the componentto assume a predetermined shape. For example, there may be a hoop (notshown) made from a polymer, a flexible metal or a shape memory materialthat is imbedded in the periphery of the exposed surface 166. The hoopor similar structure may direct the exposed surface 166 to assume thepredetermined shape, for example, an oval or a circle. As anotherexample, there may be ribs (not shown) based centrally within thesubstance of the exposed surface 166 and spreading out radially. Theribs or similar structures may direct the exposed surface 166 to assumethe predetermined shape. Reinforcement materials may also provide forstructural strength or stability in the container body 162, the exposedsurface 166 or both. For example, a net of fine metallic fibers (notshown) surrounding the container body 162 may be provided to reinforcethe container body 162 and/or to offer protection for example againstmaterial fatigue that may result from repeated flexion in response toventricular contraction and relaxation.

FIG. 6 depicts a volume reduction system 160 that can have a containerbody 162, a tissue surface 164 and an exposed surface 166. Situatedaround the periphery of the exposed surface 166 and integral therewithare a plurality of attachment devices 182 that may attach the volumereduction system 160 to the wall of the ventricle. As depicted, thereare six attachment devices 182 shaped like hooks or claws. Attachmentdevices may take a variety of shapes, including barbs, prongs,fishhooks, claws, spikes or any other shape that would attach the system160 to the surrounding tissues. The attachment devices 182 may bedetachable, so that the system 160 may be removed in its entirety. Theattachment devices 182 may be biodegradable, or may provide onlytemporary attachment. The attachment devices 182 may be of any size ornumber that provides satisfactory attachment. There may be a singleattachment device 182 or a plurality of attachment devices 182. Forexample, a large number of tiny attachment thistle-like fibers mayprovide adequate attachment. Or, for example, nanomaterials may beavailable to provide attachment. Attachment devices 182 may bepositioned anywhere upon the volume reduction system 160, and need notbe confined to the periphery of the exposed surface 166. For example, aplurality of small upwardly-directed barbs may be embedded in the tissuesurface 164 of the container body 162 providing attachment over a largearea and resisting displacement. As another example, the container body162 may be surrounded by a very fine polymeric or metallic net havingattachment devices 182 integrated therewith.

FIG. 7 depicts a volume reduction system 260 positioned within the leftventricle 112 and partitioning off from the left ventricle an interiorvolume 262 that is separated from the free flow of blood within theventricle. The path where blood flows freely within the ventricle may betermed the flow path for blood. The depicted volume reduction system 260includes an exposed surface 266 attached to and supported by a framework264. The exposed surface 266 may be shaped as a lid or a cap sealing offan interior volume 262. The framework 264 passes through the internalvolume 262 to terminate in an anchoring foot 268 that attaches theframework 264 to the ventricular wall 134.

The exposed surface 266 may be made from any biocompatible material, forexample an antithrombotic material. The exposed surface 266 can be incontact with free-flowing blood. The exposed surface 266 can be madefrom anti-thrombotic materials. The exposed surface 266 can be formedinto a shape that avoids areas of stasis. Resistance to thrombosis maybe inherent in the selected material, or it may be produced by applyinga suitable coating to or embedding a suitable antithrombotic material inthe biomaterial comprising the exposed surface 266. The exposed surface266 may have a sufficient degree of elasticity that it can respondwithout fatigue to stresses from ventricular contraction and relaxation.The exposed surface 266 may bear attachment devices (not shown) aroundits periphery to secure it in a preselected position within theventricle 112. The exposed surface 266 may incorporate a band around itsperiphery to permit tissue ingrowth for anchoring.

The exposed surface 266 may be a solid material having its own thicknessand volume. The exposed surface 266 may have a support (not shown)embedded within it. The exposed surface 266 may be made of a lightweightmaterial supported by its internal support (not shown). The geometry ofthe exposed surface 266 may be adapted to the shape of the interior ofthe ventricle 112. The exposed surface 266 may be flat, convex orconcave.

The framework 264 supports the exposed surface 266 and attaches it tothe anchoring foot 269. The framework 264 desirably has elasticproperties that permit it to respond to ventricular contraction andrelaxation without fatigue and without erosion into surrounding tissues.Suitable materials for the framework 264 may include polymers, metals,shape memory materials and the like. The framework 264 depicted in FIG.6 is comprised of ribs attached to a central tether 270. The centraltether 270 is in turn attached to the anchoring foot 268. The ribs mayspring out from the central tether and exert a radial force against theperiphery of the exposed surface 266, thereby holding the exposedsurface 266 open and supporting it against the contraction andrelaxation of the ventricle 112. Other configurations for the framework264 may be apparent to practitioners of ordinary skill. For example, theframework 264 may include a spring or a coil that assumes apredetermined shape upon release from a delivery catheter (not shown),or that forms into a predetermined shape upon exposure to bodytemperature as a shape memory material.

The framework 264 is affixed to an anchoring foot 268 that attaches theentire system 260 to the ventricular wall 134. As depicted in FIG. 7,the framework 264 attaches to a central tether 270 which in turnattaches to the anchoring foot 268. It is understood that any type ofattachment between the framework 264 and the anchoring foot 268 may beenvisioned.

The anchoring foot 268 permits attachment of the framework 264 to theventricular wall 134. The anchoring foot 268 may include barbs, hooks,anchors, claws, fasteners, screws, and the like, that allow affixationto the tissue. Configurations of the anchoring foot 268 may varydepending on the thickness of the ventricular wall 134 and/or the healthof ventricular wall 134 tissues. For example, an anchoring foot 268 mayneed a broad base without much penetrating depth in patients withthinned ventricular wall tissues. Or, for example, the anchoring foot268 may be screwed into the tissues of the ventricular wall 134 if thetissues are of sufficient thickness and strength. Other variations ofthe anchoring foot 268 will be apparent to those of ordinary skill inthe art.

An interior volume 262 exists beneath the exposed surface 266. Thisinterior volume 262 may be filled with a filling material that occupiesthe volume and provides support for the entire system 260. The fillingmaterial may be placed within a containment bag (not shown) thatoccupies the interior volume 262. The filling material may be insertedwithout any other containment besides the cap on the interior volume 262afforded by the exposed surface 266. Filling materials that occupy theinterior volume 262 may be similar to those described above. Fillingmaterials may be introduced into the interior volume 262 or into anycontainment bag therein through a fill tube, a fill port, a needle, orthe like. Moreover, a solid body or an expandable body (not shown) maybe placed within the interior volume 262 to occupy space therein.

The framework 264 may have contractile properties so that it exertstraction on the exposed surface 266 to decrease the size of the interiorvolume 262. This may allow the volume reduction system 260 to shape theventricle over time to enhance ventricular function. Similarly, materialintroduced into the interior volume 262 may have contractile properties,so that it tends to reduce the size of the interior volume 262 andreshape the ventricle over time. A valve system may permit adjustment ofinterior volume by adding or removing filling material.

While the framework 264 shown in FIG. 6 is contained within the interiorvolume 262, a volume reduction system 260 may include a framework thatsurrounds or envelops the interior volume 262. For example, a framework264 may be shaped as a coil arranged around the periphery of theinterior volume 262 that supports the exposed surface 266. As anotherexample, a framework 264 may be a balloon shaped as a coil or as aseries of toroidal structures arranged around the periphery of theinterior volume 262 and supporting the exposed surface 266. A balloonacting as a framework 264 may be filled with any of the sorts of fillermaterials previously described. The volume of a balloon framework 264may be adjusted, for example by adding or removing filler material.Employing a balloon as a framework 264, filling the balloon may enhancethe anchorage of the volume reduction system 260 within the ventricle112. The toroidal structure or balloon system may act as solid orexpandable bodies occupying space within the interior volume 262, andmay not act as a framework or support.

FIG. 8 illustrates that the volume reduction system 260 can have a firstconfiguration that is substantially straight. The first configuration ofthe volume reduction system 260 can be in a relaxed or a stressed andbiased state. The volume reduction system 260 can have a rigid orflexible frame 300. The frame 300 can have one or more wires, rods,shafts, ribbons, or combinations thereof. The frame 300 can be hollowand/or solid. The volume reduction system 260 can have one or moreatraumatic tips 302 at the proximal and/or distal ends of the volumereduction system 260. The atraumatic tips 302 can be rounded, bulbous,softened, or combinations thereof.

FIG. 9 illustrates that the volume reduction system 260 can have thecontainment system 130 on the frame 300. The containment system 300 canbe in a deflated configuration. The containment system 130 can have oneor more fill ports 122 at the proximal and/or distal ends of thecontainment system 130. The fill ports 122 can be self-sealing.

FIG. 10 illustrates that the frame 300 can have a helical or spiraledrelaxed or biased configuration. The frame 300 can have a taperedconfiguration. For example, the frame 300 can have a taped helical orspiral configuration, such as a conical configuration. The frame 300and/or inflated containment system 130 (as shown in FIG. 11) can have aconfiguration that can mimic the shape of the interior of a biologicalspace, such as the apex of the left ventricle, a fallopian tube, or astomach.

FIG. 11 illustrates that the containment system 130 a helical orspiraled configuration in a wholly or partially inflated or deflatedconfiguration. The containment system 130 can have a taperedconfiguration in a wholly or partially inflated or deflatedconfiguration. For example, the containment system 130 can have a tapedhelical or spiral configuration, such as a conical configuration in awholly or partially inflated or deflated configuration.

The exposed surface 166 can have a central port 304. The central port304 can be open into a central lumen and or be covered by a port cover.

FIG. 12 illustrates that the frame 300 can be in the containment system130 when the containment system is in an inflated or otherwise expandedconfiguration.

FIG. 13 a illustrates that the containment system 130 can be filled withthe filler material 132. The containment system 130 can have no frame300 and/or the frame 300 can be less than the length of the containmentsystem 130.

FIG. 13 b illustrates that the frame 300 can be configured to besubstantially radially central to the containment system 130, forexample, when the containment system 130 is in a partially and/or fullyinflated or otherwise expanded configuration. The frame 300 can have ahollow or solid circular transverse cross-section, as shown. The frame300 can have a hollow or solid triangular, rectangular, oval, square,pentagonal, or I-beam transverse cross-section, or combinations thereof.

FIG. 13 c illustrates that one or more barbs or rails 306 can extendradially from the frame 300. The frame 300 can be attached and/orintegral with the bars or rails 206. The barbs and/or rails 306 canextend through the containment system 130 across a fluid-tight or a notfluid-tight seal.

FIG. 13 d illustrates that the frame 300 can have one or more framespines 300 a and one or more frame hoops 300 b. The frame spine 300 acan be integral with and/or directly attached to the containment system130. The frame 300 can be an exoskeleton or exoframe on the outside ofthe containment system 130. The frame 300 can be resilient ordeformable. The frame hoop 300 b can radially expand as the containmentsystem 130 is inflated or otherwise expanded. One or more barbs, rails,anchors, or combinations thereof, can extend radially from the hoop 300b.

FIG. 13 e illustrates that the frame 300 can have or be a ribbon. Theribbon can have a straight transverse cross section (as shown). Theribbon can be radially central with respect to the containment system130 and/or radial offset with respect to the containment system 130, forexample integral with and/or directly attached to the containment system130.

FIG. 13 f illustrates that the frame 300 (e.g., the ribbon) can have acurved transverse cross-section, for example, matching the curvature ofthe containment system 130.

FIG. 14 illustrates that the volume reduction system 260 can have asubstantially straight configuration in an inflated or otherwiseexpanded configuration. The volume reduction systems 260 can be deformedwhen deployed into biological spaces with anatomy non-conforming to thevolume reduction system 260. For example, the volume reduction systems260 shown in FIGS. 8, 9 and 14 can be positioned at a target site andthen deformed (e.g., by a tool and/or by pressing against the tissuewall) to substantially fit the anatomical target site.

FIG. 15 illustrates that the volume reduction system 260 can have one ormore containment system spines 310 extending longitudinally along alongitudinal axis of the volume reduction system 260. The volumereduction system 260 can have one or more sets of singular or opposingcontainment system fingers 308 extending from the containment systemspine. The frame 300 (not shown) can have one or more frame spinesand/or frame fingers.

FIG. 16 illustrates that the containment system fingers 308 at a distalend of the volume reduction system 260 can have a larger radii than thecontainment system fingers 308 at a proximal end of the volume reductiondevice 260. The containment system fingers 308 can taper along thelength of the containment system spine 310.

FIG. 17 illustrates the volume reduction system 260 in a partially orcompletely deflated or otherwise contracted configuration. FIG. 18illustrates the volume reduction system 260 in a partially or completelyinflated or otherwise expanded configuration. When partially orcompletely deflated or contracted, opposing containment system fingers308 can be substantially nearer each other than when more inflated orexpanded. FIG. 18 illustrates that the opposing containment systemfingers 308 can expand radially outward, as shown by arrows, when thecontainment system 130 is inflated or otherwise expanded. Thecontainment system fingers 308 can frictionally fit against thesurrounding anatomical surface.

FIG. 19 illustrates that a cover 312 can have radial filaments 314and/or angular filaments 316. The cover 312 can have a metal, fabric orpolymer substrate. The cover 312 can be rigid, deformable or elastic.The cover 312 can have an elasticity to provide a harmonic spring-likeeffect to increase systolic pumping force when located in the ventricle.The containment system 130 and/or frame 300 can have an elasticity toprovide a harmonic spring-like effect to increase systolic pumping forcewhen located in the ventricle. The cover 312 can be attached to and/orintegral with the central port 304. The cover 312 can be sized to coverthe central port 304 and/or the exposed surface 166.

FIG. 20 illustrates that the volume reduction system 260 can be deployedinto the left ventricle by a catheter 120. As the volume reductionsystem 260 can be stressed into a substantially straight configurationin the catheter 120. As shown by arrow 400, as the volume reductionsystem 260 exits the catheter 120, the volume reduction system 260 canrelax into a non-straight configuration, for example into a taperedhelical coil. The catheter 120, or a separate tool, can deform thevolume reduction system 260 as or after the volume reduction 260 exitsthe catheter 120. As shown by arrow 402, the catheter 120 can bepartially translated away from the deploying volume reduction system260, as the volume reduction system 260 exits the catheter 120.

FIG. 21 illustrates that the volume deployment system 260 can fully exitthe catheter 120 at a target site, for example the apex of the leftventricle. The catheter 120, and/or other fluid delivery tool, can be influid communication with the filling port 122.

FIG. 22 illustrates that the volume deployment system 260 can beseparatably attached to the outside of the catheter 120. For example,the volume deployment system 260 can be tightly wound around thecatheter 120 and attached by one or more remotely controlled latches.The catheter 120 can be positioned at the target site to locate thevolume reduction system 260 in the target site.

FIG. 23 illustrates that the volume reduction system 260 can be releasedfrom the catheter 120 at the target site, for example in the apex of theleft ventricle. The catheter 120, and/or other fluid delivery tool, canbe in fluid communication with the filling port 122.

FIG. 24 illustrates that fluid can be delivered to the containmentsystem 130. The containment system 130 can inflate, for example, fillinga substantial volume at the apex of the left ventricle.

FIG. 25 illustrates that the cover 312 can be attached at least coveringthe central port 304. The catheter 120 can be removed. The volumereduction system 260 can have radial hooks, anchors or barbs (not shownin FIG. 25). The hooks, barbs or anchors can deploy (or passively bepreviously deployed) into the surrounding tissue.

FIG. 26 illustrates that the catheter120 can be positioned through an os318 and uterus 320 and into a fallopian tube 322. FIG. 27 illustratesthat the volume reduction device 260 can exit or be otherwise releasedfrom the catheter 120 in the fallopian tube.

FIG. 28 illustrates that the volume reduction system 260 can be inflatedor otherwise expanded. The volume reduction system 260 can be configuredwith no central port 304 (whether used in the fallopian tubes 322 orelsewhere). The volume reduction system 260 can be sufficiently inflatedand/or sealed with the cover 312 to prevent transmission of spermthrough the volume reduction system 260.

FIG. 29 illustrates that the catheter 120 can be detached from thevolume reduction system 260 and removed, as shown by arrow, from thefallopian tube 322, uterus 320 and os 318.

FIG. 30 illustrates that the catheter 120 can be positioned through theesophagus 324 and into the stomach 326, for example before reaching thepyloric sphincter 328.

FIG. 31 illustrates that the volume reduction system 260 can be deployedfrom the catheter 120 by a method disclosed elsewhere herein. The volumereduction system can be generally configured as a spiral or helix arounda partial or total length of the inner surface of the stomach 326.

FIG. 32 illustrates that the catheter 120 or a separate fluid deliverytool can deliver fluid to the filling port 122. The containment system130 can inflate or otherwise expand in the stomach 326. The containmentsystem 130 can have the center port 304.

FIG. 33 illustrates that the catheter 120 and/or separate fluid deliverytool can be detached from the filling port 122 and/or the remainder ofthe volume reduction system 260. The filling port 122 can be actively orpassively sealed.

FIG. 34 illustrates that the central port 304 can be in fluidcommunication with a central conduit 330. The central conduit 330 canpermit material (e.g., food, fluid) to flow through the stomach 326. Thecontainment system 130 can block a portion of the stomach surface fromsubstantially interacting with contents of the stomach 326. Thecontainment system 130 can occupy volume in the stomach 326.

The volume reduction system 260 can be removed from the target site, forexample the fallopian tube 322, ventricle, or stomach. The volumereduction system 260 can be removed, for example by forcible removal, bydraining or otherwise contracting and then translating, or combinationsthereof. One or more holes can be drilled through the volume reductionsystem 260 and/or the cover can be removed, for example to reversesterilization caused by deployment in the fallopian tubes 322.

Inflation of the volume reduction system 260 in vivo can partially orcompletely occur due to absorption of bodily fluids. For example, thevolume reduction system 260 can be made from polypropylene.

It is apparent to one skilled in the art that various changes andmodifications can be made to this disclosure, and equivalents employed,without departing from the spirit and scope of the invention. Elementsshown with any variation are exemplary for the specific variation andcan be used on or in combination with any other variation within thisdisclosure.

1. A ventricular chamber volume reduction system, wherein theventricular chamber has an apex and a wall, comprising: a framecomprising an anchor radially extending from the frame; a containmentdevice deliverable through an intravascular catheter into a ventricularchamber and expandable from a collapsed shape to a filled shape oncedelivered into the ventricular chamber; and a filler within thecontainment device, wherein the filler expands the containment devicefrom the collapsed shape to the filled shape; and wherein thecontainment device is configured to fit to the contour of theventricular chamber wall extending from the apex of the ventricularchamber to the surface of the containment device farthest away from theapex, and wherein the containment device is configured to substantiallyfill the volume between the surface of the containment device farthestaway from the apex and the apex.
 2. The system of claim 1, furthercomprising a partition, wherein the partition is adjacent to thecontainment device, wherein the partition is positioned on the side ofthe containment device away from the apex.
 3. The system of claim 2,wherein the partition is resilient.
 4. The system of claim 1, whereinthe containment device comprises a substantially conical configuration.5. The system of claim 1, wherein the filler is curable.
 6. The systemof claim 1, wherein the filler comprises a polymer.
 7. The system ofclaim 1, further comprising attachment mechanisms that affix thecontainment device to a wall of the ventricular chamber.
 8. The systemof claim 1, further comprising a fillport for the containment device. 9.The system of claim 1, wherein the containment device is configured sothat the volume within the containment device is adjustable after thecontainment device is delivered to a target site.
 10. A ventricularchamber volume reduction system, comprising: a frame comprising ananchor extending radially from the frame; a container body deliverableinto a portion of a ventricular chamber, and wherein the container bodyis expandable from a first shape to a second shape when delivered intothe ventricular chamber, the container body having a tissue surface incontact with a wall of the ventricular chamber and an exposed surfacefacing into the volume of the ventricular chamber not occupied by thecontainer body, and wherein the exposed surface substantially spansacross the ventricular chamber, wherein the container body comprises afillport, and wherein the container body is attached to the frame,wherein the second shape of the container body occupies substantiallyall of the space in the ventricular chamber between the wall of theportion of the ventricular chamber and the exposed surface, and whereinthe second shape of the container body is in contact with the wall fromthe apex of the ventricular chamber to the surface of the containerfarthest away from the apex, thereby reducing ventricular volume exposedto a flow of blood.
 11. The system of claim 10, further comprising apartition, wherein the partition is positioned on the side of thecontainer adjacent to the exposed surface.
 12. The system of claim 10,wherein the container body comprises an attachment device that affixesthe tissue surface to the wall of the ventricular chamber.
 13. Thesystem of claim 10, wherein the containment body is configured so thatthe volume within the containment body is adjustable after thecontainment device is delivered to a target site.
 14. The system ofclaim 10, wherein the second shape of the container body is configuredto conform with the wall of the apex of the ventricular chamber.
 15. Aventricular chamber volume reduction system, comprising: a framecomprising an anchor extending radially from the frame; a partitionsequestering a portion of a ventricular chamber, thereby substantiallyremoving the portion from a flow path for blood flowing within theventricular chamber, the partition having an exposed surface facing theflow path, wherein placement of the partition decreases volume of bloodflowing along the flow path within the ventricular chamber, and whereinthe partition is resilient; and a fillable container volume having asubstantially open central port, the container volume configured to bepositioned between the partition and the apex portion of the ventricularchamber, wherein the container is configured to contact the wall of theventricular chamber from the apex extending to the terminal end of thecontainer adjacent to the partition, and wherein the container isconfigured to allow the resilient movement of the partition within thecentral port.
 16. The system of claim 15, wherein the partition isattached to the fillable container.
 17. The system of claim 15, whereinthe partition is configured to be attached to a tissue surface of thewall of the ventricular chamber.
 18. The system of claim 15, wherein thepartition comprises with an antithrombogenic material.
 19. The system ofclaim 15, wherein the fillable container is configured so that thevolume within the fillable container is adjustable after the fillablecontainer is delivered to a target site.
 20. The system of claim 15,wherein the fillable container is configured to conform with the wall ofthe apex of the ventricular chamber.